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UPDATED RECALL NOTICE: HeartSine samaritan PAD 350P, 360P and 450P AEDs

MEDAIRE IS ASSESSING A RECENT MANUFACTURER RECALL NOTIFICATION AFFECTING CERTAIN HEARTSINE SAMARITAN PAD AEDS.

MedAire is aware of the recent recall notification affecting certain HeartSine® samaritan® PAD 350P, 360P, and 450P AEDs (Recall No. PR3977961-FA318/FA319). We are actively identifying potentially affected units and will notify impacted customers with next steps and any actions required.

Current guidance

According to the manufacturer's recall documentation, affected AEDs should remain in service and continue to be used as normal until a replacement or alternative solution is available. The manufacturer has indicated a low probability of device failure.

 

Affected products

  • HeartSine® samaritan® PAD 350P
  • HeartSine® samaritan® PAD 360P
  • HeartSine® samaritan® PAD 450P

Recall reference: PR3977961-FA318/FA319

What MedAire is doing

MedAire is actively identifying potentially affected units and will notify impacted customers with next steps and any actions required.

What customers should do now

  1. Keep affected AEDs in service.
  2. Continue to use affected AEDs as normal until a replacement or alternative solution is available.
  3. Watch for direct communication from MedAire if an affected unit is identified.
  4. Review the manufacturer notice linked below for device identification instructions and Stryker contact information.

Manufacturer notice

Download the Stryker recall notification (PDF)

 

The manufacturer's documentation includes affected device identification instructions and Stryker contact information.

Updates and next steps

For additional information regarding this recall, visit MedAire.com > Resources > Recalls and Notices for the latest manufacturer notices and guidance.